NCT05446805

Depression and Driving

The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Ganesh Babulal · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: —

Summary

This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).

Detailed description

The long-term goal is to accurately identify who is at risk of decline in driving, to forecast when decline will occur, and to intervene before decline, thereby reducing the numbers of crashes, injuries, and death in older adults. The findings indicate that the long preclinical stage of Alzheimer disease (AD), as reflected in amyloid imaging and cerebrospinal fluid (CSF) biomarkers among cognitively normal participants, is associated with poorer driving performance on a standardized road test. This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).

Conditions

• Depression
• Drive

Interventions

Type	Name	Description
DRUG	F 18 AV-1451 (Flortaucipir)	A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for \[18F\] AV-1451. A PET-certified medical professional will prepare and administer the \[18F\] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of \[18F\] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).
DRUG	[11C]-Pittsburgh Compound B ([11C]PiB)	A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for \[11C\] PIB. A PET-certified medical professional will prepare and administer the \[11C\] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of \[11C\] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.

Timeline

• Start date: 2021-06-17
• Primary completion: 2026-06-17
• Completion: 2026-12-17
• First posted: 2022-07-07
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study